Clinical Study 3MESPE Crowns
Clinical Pilot Study of: Astringent Retraction Paste, Imprint™ 4 VPS, Imprint 4™ Preliminary, Intra-oral Syringes, 3M ESPE New Temporary Restoration (SuPro 100 and Temporary Cement), RelyX™ Unicem™ 2 Automix Cement, Lava™ Plus Zirconia Crowns
This clinical study seeks to address four independent questions that are all part of the delivery of care associated with the provision of a single item of treatment; an indirect restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a crown requires a series of sequential clinical and laboratory stages stages:
- Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be crowned. This will be used to enable the fabrication of the temporary crown after the tooth has been prepared. This is standard care and follows established clinical protocols.
- Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space for the crown that will be fabricated to replace the missing structure.
- Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will be made to fabricate the crown. To take the impression, the dentist will need to gently push the gums away from the tooth by fractions of a millimeter so that the margins of the preparation are clearly discernible.
- Stage 4 - Provision of a temporary restoration that will provide satisfactory function for a limited period of time, until the definitive crown can be fitted. This temporary crown is designed to have a finite short-term durability and have an ease of manufacture and subsequent removal; hence the use of a specific cement that will enable this.
- Stage 5 - Fitting of the definitive restoration. This is designed to be a durable restoration, with a mean life expectancy measured in years, but which is ultimately determined by a number of clinical, biological and patient specific parameters. Definitive restorations are fitted with cement designed to retain the crown in permanent manner.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sheffield、英国
- Sheffield NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients in need of at least one full-coverage posterior restoration (crown) in a permanent premolar or molar.
- If two teeth in opposing arches are in need of a full-coverage posterior restoration (crown) only the tooth or teeth in one arch will be included in the study.
Exclusion Criteria:
- Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155 will not be enrolled.
- Patients with contraindications as described in the 'Instructions for Use' of the study materials
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:Innovation treatment 3M ESPE materials
The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment during the Impression intervention. Materials to be used all 3M ESPE - Astringent Retraction Paste, Imprint™ 4 Preliminary, Imprint™4 VPS, Imprint™ 4 Bite, Intra-oral syringes, Impression Tray, |
The 1st intervention will compare two clinical impression techniques The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment.
The standard clinical practice treatment will receive the standard clinical practice treatment first and then crossover to receive the innovation treatment.
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其他:standard clinical practice treatment
The standard clinical practice treatment will receive the standard clinical practice treatment first and then crossover to receive the innovation treatment during the Impression intervention Materials as per the operating dentist's choice to be recorded on CRF |
The 1st intervention will compare two clinical impression techniques The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment.
The standard clinical practice treatment will receive the standard clinical practice treatment first and then crossover to receive the innovation treatment.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Assessment of the predictability
大体时间:48 months
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Assessment of the predictability of results as a function of accuracy of the resulting model, the dentist's judgment on the quality of impression and the accuracy of fit of the definitive restoration (Lava™ Plus Zirconia crown).
Predictability is defined as the frequency in which an adequate result is obtained in a consistent manner
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48 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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